(86 days)
RTist is a software application, intended to display and visualize 2D & 3D multimodality (i.e. CT, MRI, and PET) medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks at distributed locations utilizing standard PC hardware.
The volume and linear measurement functions are intended for evaluation and quantification of turnor measurements, location/displacement study, analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of 'avoidance' structure(s) during critical evaluation.
Typical users of this system are trained professionals, including but not limited to radiologists, clinicians and technicians. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.
The RTist is a software application acting as a stand alone Picture Archiving and The relise is a betting (PACS). It may be marketed as the software only as well as packaged with a standard 'off the shelf' PC Hardware. It is in effect a 'plug in' publication to the Fusion 7D/ Miraview / Reveal - MVS software platform (reference K020546) but is effectively 'vendor' neutral and as such an enhancement to many other medical image/ data management systems.
The comprehensive array of features provided by the software allows the medical professional to visualize, review, interpret, manipulate, render and distribute medical image data stored in DICOM format. The networking component of the product allows the exchange of medical image data with any other DICOM-compatible or FTPcompatible server over a standard TCP/IP network.
The RTist receives images in DICOM format, which are then converted into volume data format using core software technology. The RTist viewer provides interactive orthogonal and multi-planar reformatting which enables the user to evaluate abnormality or malformation displayed in the image. The volume and linear measurement features provided by the software enable evaluation and quantification of region of interest volume, linear measurements and location/displacement.
The software also supports interactive segmentation of the region of interest (ROI), automated contouring of multi-slice ROI and labeling of structure(s) during critical evaluation.
RTist processes an array of medical images including anatomical images (e.g. CT and conventional MRI), and functional images (e.g. SPECT and PET).
The RTist software incorporates standard visualization features to display the input DICOM data and the results of the registration operations.
The provided text is a 510(k) summary for the RTist software application. It describes the device, its intended use, and lists predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria based on the provided text. The document is essentially a regulatory submission summary, not a clinical trial report or a performance validation study.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).